Trials / Unknown
UnknownNCT03642496
Clinical Study of ET019002-T Cell Therapy for Refractory/Relapsed B-Cell Malignancies
The Clinical Study of Structurally Optimized ET019002-T Cell Therapy for Refractory/Relapsed B-Cell Malignancies
- Status
- Unknown
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
- Sex
- All
- Age
- 6 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This study is to determine the safety, including potential dose limiting toxicities, and efficiency of ET019002-T cells and the duration of in vivo survival of ET019002-T cells in patients with relapsed/refractory B-Cell Malignancies.
Detailed description
ET019002-T cell therapy is a novel chimeric T-cell therapy platform that in preclinical studies, functionally matches the efficacy of CAR-T cells, but dramatically reduces the release of cytokines upon killing of target-positive tumors.The arm of the study is experimental i.v. arm:ET019002-T cells administered by intravenous (IV) infusion.The intervention is ET019002-T cells(Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET019002)-expression construct).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Low dose ET019002- T Cells | ET019002- T Cells are autologous T cells transduced expressing a novel anti-CD19 (ET019002) chimeric antigen receptor,and are administered by intravenous infusion with the dose of 0.75×10\*6/kg. |
| BIOLOGICAL | Middle dose ET019002- T Cells | ET019002- T Cells are autologous T cells transduced expressing a novel anti-CD19 (ET019002) chimeric antigen receptor,and are administered by intravenous infusion with the dose of 1.5×10\*6/kg. |
| BIOLOGICAL | High dose ET019002- T Cells | ET019002- T Cells are autologous T cells transduced expressing a novel anti-CD19 (ET019002) chimeric antigen receptor,and are administered by intravenous infusion with the dose of 3.0×10\*6/kg. |
Timeline
- Start date
- 2018-08-19
- Primary completion
- 2020-08-19
- Completion
- 2020-09-20
- First posted
- 2018-08-22
- Last updated
- 2018-08-23
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03642496. Inclusion in this directory is not an endorsement.